Label: OOSAFE DISINFECTANT- benzalkonium chloride liquid

  • NDC Code(s): 52759-922-00, 52759-922-01, 52759-922-05, 52759-922-10
  • Packager: SparMED ApS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 19, 2017

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  • Purpose
  • Application
  • Dosage Administration
  • Active Ingredients
  • Inactive Ingredients
  • Warning
  • Keep Out of Reach
  • Oosafe 250 ml label
  • INGREDIENTS AND APPEARANCE
    OOSAFE  DISINFECTANT
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52759-922
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R) 991 g  in 1 L
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 3.7 g  in 1 L
    SODIUM NITRITE (UNII: M0KG633D4F) 4 g  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52759-922-01 1 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
    2 NDC:52759-922-05 5 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
    3 NDC:52759-922-10 10 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
    4 NDC:52759-922-00 0.25 L in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/30/2012
    Labeler - SparMED ApS (311811306)
    Close